A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07570173
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-1045 — BIOLOGICAL
    Intravenous administration
  • Blinatumomab — BIOLOGICAL
    Intravenous administration
  • Acetaminophen — DRUG
    Oral administration as a premedication
  • Diphenhydramine — DRUG
    Intravenous administration as a premedication
  • Dexamethasone — DRUG
    Intravenous administration as a premedication
  • Tocilizumab — DRUG
    Intravenous administration as a rescue medication
  • Siltuximab — DRUG
    Intravenous administration as a rescue medication
  • Avtozma — DRUG
    Intravenous administration as a rescue medication
  • Tyenne — DRUG
    Intravenous administration as a rescue medication

Study Details

Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This trial will compare MK-1045 to a standard immunotherapy called blinatumomab. The goals of this trial are to learn if more people who receive MK-1045 have no cancer cells in their bone marrow compared to people who receive blinatumomab and if people who receive MK-1045 live longer compared to people who receive blinatumomab.

Key Dates

Start date
May 18, 2026
Status verified
Jun 2026
Primary completion
Oct 18, 2033
Completion
Oct 18, 2033

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MK-1045 Dose Regimen A
    Participants will receive a lower MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1.
  • Experimental: MK-1045 Dose Regimen B
    Participants will receive a larger MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1.
  • Active Comparator: Blinatumomab
    Participants will receive blinatumomab on days 1, 8, 15, and 22 of each 42-day cycle

Primary Outcome Measure

Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2 [ Time Frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm) ]

Central Contacts

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